· Raising Change request and action plan in a Trak wise system.
· Change request Close out after completion of task as per the action plan and trackability of action plan.
· IOPQ Server qualification and Network qualification documentation preparation.
· IT Standard operation procedure (SOP) preparation and implementation.
· Audit support for IT related compilation and support.
· IT documents and Bound book reconciliation with QA department and excel sheet maintenance.
· New project related documentation preparation, execution, technical support and project finalization as below. Ø Impact assessment Ø URS Ø Design qualification Ø IOPQ qualification Ø FMECA (calculation and RPN scoring)
· FMECA CFT document
· Justification for FMECA
· Risk communication
· Quality management system (QMS) preparation and handling as below. Ø Raising Deviation in Track wise system Ø CFT Meeting arrangements Ø Investigation report preparation Ø Smart Root cous Analysis Ø 5 Why analysis, Faulty tree and fish bone Ø Rubric Ø Training reports and person interviews.
Ø CAPA Ø After deviation closer CAPA trackability and CAPA implementation Ø CAPA effectiveness check Ø Responsible for handling Commvault Backup as follow:
· CommCell Setting Overview.
· Client configuration (Server and Endpoint) with Commvault.
· Backup configuration with Commvault (Application, File system, Virtual).
· Restoration of backup (Application, File system, Virtual).
· Media Management
· Assign A, B, C, D Weekly and Monthly Media Tape in Autoloader.
· Media management and Storage in Fireproof cabinet at Security Gate unit Extension.
· Daily backup Job monitoring
· Backup validation of all PTG site applications.
· Backup validation schedule preparation of all applicable departments.
· Logbook monitoring and maintained.
· Making entry in Error History log failed client and server.
· Resolve the failed backup client and servers.
· Daily, Weekly, monthly and yearly Backup report signs out through EM signer application, client Disk, client Tape Out, server Disk and Server Tape Out.
Requirements
- Pharma background in IT is mandatory.
- Should be ready to work in shifts.
- Should have work experience on GxP systems, Pharma audits, Documentations.
- Should have strong communication skills to handle audits.